Devices and methods for prevention, moderation, and/or treatment of cognitive injury

Inventors

Evans, Douglas G. • Thakkar, Viral S. • Gani, Matthew J.

Assignees

Lungpacer Medical Inc

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Publication Number

US-12029901-B2

Patent

Publication Date

2024-07-09

Expiration Date


Abstract

This disclosure describes methods and systems for preventing, moderating, and/or treating brain injury. The methods herein may include obtaining a test result reflecting a condition of a brain in the subject, determining a stimulation parameter based on the test result, and stimulating a nerve based on the stimulation parameter, wherein stimulation of the nerve assists or causes contraction of a respiratory muscle in the subject. The systems herein may include a processor configured to: receive a test result reflecting a condition of a brain in a subject, and determine a stimulation parameter based on the test result; and a stimulator configured to stimulate a nerve based on the stimulation parameter, wherein stimulation of the nerve assists or causes contraction of a respiratory muscle in the subject.

Core Innovation

The invention provides methods for treating a subject by coordinating neuromodulation with mechanical ventilation and brain-based closed-loop adjustment. A first stimulation signal stimulates a first nerve with an amount of a stimulation parameter, where the stimulation parameter includes a stimulation charge, a frequency of pulses within a stimulation train, or a breath rate, and stimulation assists or causes contraction of a respiratory muscle while ventilation affects the brain.

While the subject is ventilated with a mechanical ventilator, a test result is generated by imaging a brain, measuring brain oxygenation, or measuring intracranial pressure, wherein the test result comprises an effect of ventilation on the brain. The test result is compared to a predetermined value or predetermined value or range to determine a condition of the brain, and the amount of the stimulation parameter is modified based on the determined brain condition.

The methods then apply a second stimulation signal with the modified amount of the stimulation parameter so that stimulation assists or causes contraction of the respiratory muscle. In parallel, transmission of an aberrant signal is inhibited by a second nerve during ventilation, and in related embodiments vagus nerve activity is quantified and used to generate a stimulation parameter that governs phrenic nerve stimulation with an electrode more proximate to the phrenic nerve than a vagus nerve.

Claims Coverage

The document provides three independent method claims that share a closed-loop concept using ventilation-linked brain or nerve test results to modify a stimulation parameter for respiratory muscle contraction, including embodiments that inhibit aberrant signal transmission and quantify vagus nerve activity.

Brain effect test result for modifying stimulation parameter

A test that provides a test result comprises an effect of ventilation on the brain from the mechanical ventilator, and the test result is compared to a predetermined value or predetermined value or range to determine a condition of the brain, and the amount of the stimulation parameter is modified based on the condition of the brain.

Respiratory muscle contraction via nerve stimulation with adjustable parameter

Stimulating a first nerve with a first stimulation signal including an amount of a stimulation parameter that includes stimulation charge, a frequency of pulses within a stimulation train, or a breath rate, wherein stimulation assists or causes contraction of a respiratory muscle; then stimulating with a second stimulation signal that includes the modified amount of the stimulation parameter.

Concurrent inhibition of aberrant signal by a second nerve

While stimulating the first nerve, inhibiting transmission of an aberrant signal by a second nerve during mechanical ventilation, and then stimulating the first nerve again using the modified amount of the stimulation parameter.

Quantification of vagus nerve activity to generate stimulation parameter

Quantifying vagus nerve activity in the subject, wherein the quantification includes an effect of mechanical ventilation on the vagus nerve activity, obtained by testing heart blood flow, testing peripheral blood flow, testing blood pressure, imaging, or assessing inflammation or pain-related molecules in blood; generating a stimulation parameter based on the quantification of vagus nerve activity; and stimulating the phrenic nerve with an electrode more proximate to the phrenic nerve than a vagus nerve using a stimulation signal that includes the stimulation parameter.

Phrenic nerve stimulation used with selective exclusion of vagus nerve

Stimulating the nerve with the second stimulation signal includes stimulating a phrenic nerve and does not include stimulating a vagus nerve.

Across the independent claims, the central claimed coverage is a ventilator-associated closed-loop process that derives a brain- or vagus-linked test or quantification, compares it to a predetermined value or range, modifies an amount of a stimulation parameter, and delivers a second nerve stimulation to assist or cause respiratory muscle contraction, including embodiments that inhibit transmission of an aberrant signal by a second nerve and that use electrode proximity to differentiate phrenic from vagus stimulation.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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